Device for providing anti-reflux in a body fluid collection and/or sampling system, and method of manufacturing such a device

ABSTRACT

A body fluids drainage system includes a urinary catheter, a drainage collection bag, and a connection member connected between the urinary catheter and the drainage collection bag. The connection member houses a valve element formed from a sheet of material and projecting a coherent plane. The valve element defines a longitudinal direction extending between a connecting portion and a flap portion and a recess formed on a periphery of the valve element between the connecting portion and the flap portion.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a device for providing anti-reflux in abody fluid drainage and/or sampling system comprising at least one partproviding a valve seat, and a valve element defining an outer contourformed from a sheet-shaped material blank, said valve element includingat least one connecting portion and a flap portion and defining alongitudinal direction extending between the connecting portion and theflap portion, and retaining means for retaining the valve element withrespect to the device, said retaining means being integral with thedevice.

2. Description of the Related Art

Devices for preventing backflow or reflux in systems for drainage and/orsampling of body fluids are well known in the art. Such devices, whicheither constitute or have the function of valves, may e.g. be positionedin a connector member connecting a urinary catheter with a urinedrainage bag and prevent reflux of the collected urine to the catheter.

There are various designs of such devices. One type of valve which hasproven efficient and which is at the same time of a simple structure isthe flap or flutter type of valve. In such a valve, a relatively thinflap serves as a valve element and is connected with one or more partsof the device in such a way that the flap is able to flex or pivotbetween an open and a closed position. In the closed position, the flapabuts against a valve seat formed on any of the parts of the system. Theflap thus allows for passage of fluid in one direction and seals againstthe valve seat when fluid pressure is exerted in the opposite direction.

The connection between the valve element and the other part or parts ofthe device may be carried out in different ways. One example is shown inGB patent application No. 2 313 430, in which a flap is formed as theinner portion of a hollow tubular structure forming a valve element. Theflap of the valve element is connected integrally with a surroundingconnecting portion at one point only and is thus separated from theconnecting portion by a C-shaped slot. A simpler version of the sameprinciple is disclosed in U.S. Pat. No. 3,529,599, in which the valveincludes a disk-shaped valve element with a corresponding C-shaped slot.During manufacture of such a valve element, great care must be observedduring provision of the slot, as the cut-out material produced mayinterfere with the manufacturing process and may, at worst, causecomplete shutdown, just as any residual material on the cutting surfacemay affect the sealing properties of the valve. Furthermore, in order toobtain a correct seal, the valve seat of both of the above devices mustextend radially inwards of the flap portion. Consequently, the overalldimensions of the anti-reflux device are necessarily relatively large inrelation to the available inner dimensions of the tubes of the system.

U.S. Pat. No. 3,901,235 discloses an anti-reflux device positioned atthe drip chamber of a body fluid collection bag, in which the valveelement is relatively large and is sealed to the drip chamber around amajor part of its periphery, leaving only the lower periphery free topivot and allow for passage of fluid. However, as the flap portion thusonly constitutes a small part of the valve element, there is a largeamount of surplus material that does not take part in the actualfunction of the device. Furthermore, the sealing operation entails thatthe manufacture of the device becomes more complicated.

U.S. Pat. No. 3,968,925 discloses an anti-reflux valve located at thedrip chamber of a fluid drainage bag, in which connecting portions ofthe valve element are formed as two radially extending ears protrudingfrom the flap portion. The ears are received in retaining pockets formedunder a separate retaining member in the form of a strip bonded to thedrip chamber forming the valve seat. As the strip is only bonded to thedrip chamber at selected portions, the valve element is slidablyreceived in the pockets. In addition to the fact that such a slidableand thus immediately releasable connection is not desirable for allpurposes, the manufacture and assembly of such a device is renderedexpensive and cumbersome by the separate retaining member, itsattachment to the drip chamber and the positioning of the valve element.

Furthermore, a commercially available device is known in which the valveelement has the shape of a substantially cylindrical flap portion and aconnecting portion, in which two apertures are formed for theaccommodation of retaining means in the form of protrusions such asupstanding pins or the like. The valve elements including the aperturesare usually formed by any suitable cutting operation, such as punching,of a blank of material. Due to the characteristics of the materialstraditionally used in such valve elements and to the dimensions of thedevices, difficulties may arise during manufacture of the valveelements. Such difficulties include that the cut-out or punched-outmaterial in the form of free waste corresponding to the apertures mayadhere to the valve elements due to static electricity generated by thehandling of the material. In addition to the fact that the free wastemay complicate the manufacturing process and the assembly of the deviceand render the valve leaking, it may have severe consequences if suchfree waste tears itself loose during use of the system and moves toother parts of the body fluid drainage and/or sampling system.Consequently, precautions in the form of an additional production stepmust be taken in order to secure that the free waste is removed duringmanufacture of the device.

SUMMARY OF THE INVENTION

With this background it is an object of the present invention to improvea device of the kind mentioned in the introduction with respect to easeand efficiency of manufacture, and which at the same time provides for asecure retention of the valve element in the device.

This and further objects are met by the provision of a device of thekind mentioned in the introduction, which is characterized in that theconnecting portion includes engagement means formed integrally with thevalve element for engagement with said retaining means, the valveelement projecting a coherent plane. In this relation the term‘coherent’ means that no material has been stamped, punched or cut out,i.e. no material has been removed from within the outer contour of thevalve element. Slits may be provided within said outer contour, as longas no material is removed from the valve element.

The invention provides a device of the kind mentioned in theintroduction, which is characterized in that the connecting portionincludes engagement means formed integrally with the valve element forengagement with said retaining means, the sheet-shaped material beingintact in said valve element.

The provision of integral engagement means in the valve element, whichleave the material intact, entails that the disadvantages connected withthe free waste produced during manufacture of the prior art devices areeliminated, both during the manufacturing process and in the finishedproduct.

In a preferred embodiment, the engagement means include at least oneincision and preferably two incisions in said outer contour, saidincision or incisions extending substantially transverse with respect tosaid longitudinal direction, said incision or incisions being preferablyformed at the transition between the flap portion and the connectingportion. This provides for a reliable connection between the valveelement and the retaining means of the device, and an optimum use of thematerial and at the same time, the dimensions of the flap portion andthe connecting portion may be chosen in an advantageous manner.

In order to improve the retention of the valve element with respect tothe retaining means even further, the engagement means may include ahook-shaped section positioned outwards of said at least one incisionwith respect to said longitudinal direction.

In an embodiment, which is particularly advantageous with respect tomanufacturing conditions, the outer contour forms a curve defining acontinuously advancing function on a respective side of the longitudinaldirection.

In an alternative embodiment, the engagement means are formed withinsaid outer contour. This provides for a particularly compact design ofthe valve element.

The engagement means are advantageously provided as at least one slit inthe sheet-shaped material.

In one embodiment of the invention the engagement means are formedintegrally in said outer contour.

The body fluid to be collected and/or sampled may be of any conceivablekind. However, the device is particularly advantageous for applicationsin which the body fluid is urine.

In one embodiment of the invention the valve seat providing partconstitutes a connector for connection with a urinary catheter, formspart of a hose in said system or of a sample port device.

One embodiment of the invention relates to a valve element including atleast one connecting portion and a flap portion and defining alongitudinal direction extending between the connecting portion and theflap portion, and with engagement means integrally formed in the valveelement, wherein the valve element including the engagement means ismanufactured by cutting along a closed line in a sheet-shaped materialblank.

One embodiment relates to a method of manufacturing a device forproviding anti-reflux in a body fluid drainage and/or sampling system,comprising providing at least one part including a valve seat, forming avalve element defining an outer contour from a sheet-shaped materialblank, said valve element including at least one connecting portion anda flap portion, providing retaining means integral with the device, andbringing the connecting portion into engagement with the retainingmeans, wherein engagement means are formed integrally with the valveelement, the valve element projecting a coherent plane.

One embodiment of the invention relates to a method of manufacturing avalve element in a body fluid drainage and or sampling system having aconnection portion, a flap portion, and engagement means integrally inthe valve element comprising the step of cutting the valve element andthe engagement means along one closed line in a sheet-shaped materialblank.

One embodiment relates to a method of manufacturing a valve element in abody fluid drainage and or sampling system having a connection portion,a flap portion, and engagement means integrally in the valve elementcomprising the step of cutting the valve element along one closed linein a sheet-shaped material blank; and cutting at least one slit in thesheet-shaped material leaving no waste material.

Although many of the embodiments have a connection portion, which issymmetrical around a horizontal axis, it will readily be appreciatedthat the upper and the lower part of the connection portion can havedifferent profiles.

As is well known by the skilled person, the cutting operation may beperformed by punching, stamping or die-cutting, preferably in a rollingoperation, or by using any other suitable technique such as cutting bywater or laser.

Further details and advantages are readily appreciated from the appendeddrawings and the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be described in further detail withreference to the schematic drawings, in which like references are usedfor like elements, and in which

FIG. 1 shows an exploded perspective view of a device according to anembodiment of the invention,

FIG. 2 shows a plan view, on a larger scale, of a detail of the deviceshown in FIG. 1,

FIGS. 3 to 22 show plan views of alternative embodiments of a detail ofthe device according to the invention, and

FIGS. 23 to 25 shows sectional views of details of the device accordingto the invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The object of the invention provides two different principles formovement of the valve element, namely one where the valve element isfixed in the flow direction at the connecting portion, which calls forthe valve element to flex to allow the valve to function properly, andthe other where the valve element has some clearance in the flowdirection so as to allow the valve element to pivot freely around theretaining means, the latter principle not necessarily requiring anyflexibility of the material of the valve element. The two principles mayalso be combined.

Thus, the sheet-shaped material forming the blank can be chosen withregard to the applied principle(s) of movement.

In one aspect of the invention the contact surface, between theconnection portion of the valve element and the retaining means isminimised, thereby reducing the friction, enabling the valve element topivot more freely around the retaining means.

In another aspect of the invention the clearance between the connectionportion of the valve element and the retaining means is minimised,providing the possibility of maximum control of the valve elementregarding movement in the plane, in which the valve element extends,e.g. lateral movement.

In yet another aspect of the invention the retaining means are in theshape of pins. This will entail an improved flow through the valve, ascavities making up dead spots created by integral retaining means in theshape of integrated walls are eliminated. These dead spots impeding thefree flow of the fluid are especially undesirably, since they increasethe risk of bacterial growth and other possible accumulation of materialin the system.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention is now explained more in detail with reference to thedrawings showing preferred embodiments of the invention.

A device for providing anti-reflux, i.e. for preventing backflow orreflux, in a body fluid drainage and/or sampling system is generallydesignated 1 in FIG. 1. The device 1 comprises a first part 2, which inthe embodiment shown constitutes a connector having connecting means 3for releasable interconnection with e.g. a discharge tube (not shown) ofa urinary catheter, and a second part 4 intended for connection with thefirst part 2 at one end 5. At an opposite end 6 of the second part 4connecting means (not shown in detail) are provided for connection withe.g. a tube or hose (not shown) leading to e.g. a collection bag for thebody fluid. The second part 4 furthermore comprises an opening 7 for thetaking of a sample of the fluid. The above details of the device are notessential to the present invention. The device could be positioned inother parts of the system as well. Examples of such alternativepositions are: in a hose or tube member of the system, or in a sampleport device. The device may also be utilized in connection with otherbody fluids than urine, but also in connection with other fluids as wellas gasses.

The first part 2 and the second part 4 each has a through-going cavity,of which only the cavity 8 of the first part 4 is clearly visible. Thecavities are intended to lead the body fluid from e.g. the catheter tothe collection bag. In order to prevent body fluid from flowing in theopposite direction, a valve element 9 is inserted between the first andsecond parts 2,4. The valve element 9, which will be described infurther detail in the following, is accommodated in the first part 2 andis retained in its position by means of integral retaining means. Theintegral retaining means include two protrusions 10 a,10 b formedintegrally with the inner wall of the first part 2. These protrusions 10a,10 b split the space in which the valve element 9 is accommodatedpartly in two, i.e. a recess 11 on one side and a section forming avalve seat 12 on the other. The second part 4 may be provided with oneor more protrusions corresponding to the recess 11 such that the valveelement 8 is securely retained in the first part 2. In case fluid forsome reason should flow or be pressed back in the direction from thesecond part 4 to the first part 2, the valve element 9 is brought intoabutment with the valve seat 12 surrounding the cavity 8, and backflowinto the first part 2 and further into e.g. the catheter is prevented.

The structure of the valve element 9 is shown in further detail in FIG.2. The valve element 9 includes a connecting portion 13 and a flapportion 14. In the embodiment of FIGS. 1 and 2, the shape of the valveelement 9 as defined by its outer contour 15 and a longitudinaldirection illustrated by a longitudinal line 16 is such that an incision17,18 is formed at the transition between the flap portion 14 and theconnecting portion 13 on either side of the longitudinal line 16. Eachof the incisions 17,18 extends substantially transverse with respect tothe longitudinal direction of the valve element 9, however as indicatedin FIG. 2 with a slight inclination in the direction of the connectingportion 13. Outwards of the incisions 17,18, as seen with respect to thelongitudinal line 16, a hook-shaped section 19,20 is formed on theconnecting portion 13. The incisions 17,18 and the hook-shaped portions19,20 form part of integral engagement means of the valve element 9. Aswill be described in further detail in connection with the descriptionof the embodiment of FIG. 3, the provision of integral engagement meansentails a number of advantages during manufacture as well as in use ofthe device. During manufacture of the device these integral engagementmeans are brought into engagement with the retaining means of the firstpart 2, as the connecting portion 13 of the valve element 9 is placed inthe recess 11. The form-locking engagement between the incisions 17,18and the hook-shaped sections 19,20 of the valve element 9 and theprotrusions 10 a,10 b of the first part 2 prevents that the valveelement 9 is moved from its accommodation in the first part 2.

It is noted that in the embodiment shown, the valve element 9 issubstantially symmetrical with respect to the longitudinal line 16.However, other configurations of the valve element 9 are of courseconceivable, including those in which the incisions are not of the sameshape. Furthermore, the first part 2 and the second part 4 may beseparate parts which are assembled in any suitable manner. The device 1may comprise additional parts such as e.g. separate locking means forkeeping the first and second parts 2,4 in an assembled state.

In FIG. 3 another embodiment of a valve element 9 is shown. Onlydifferences from the embodiment shown in FIGS. 1 and 2 will be describedin detail. The valve element 9 comprises a connecting portion 13 and aflap portion 14. In principle, the engagement means of the valve element9 are formed in the same manner as in the embodiment of FIGS. 1 and 2and thus include incisions 17,18 for engagement with retaining means ofe.g. the first part of the anti-reflux device. However, sections 19,20of the connecting portion 13 do not extend outwards of the incisions17,18, as the outer contour 15 of the valve element 9 forms a curvedefining a continuously advancing function on a respective side of thelongitudinal direction illustrated by longitudinal line 16. Thisentails, i.a., that during manufacture of the valve element 9, only twopoints at a time need to be cut when the valve element 9 is cut out of ablank of sheet-shaped material 30. The cutting operation may beperformed by punching, stamping or die-cutting, preferably in a rollingoperation, or by using any other suitable technique such as cutting bywater or laser.

A further embodiment of the valve element 9 is shown in FIG. 4, wherethe connection portion 13 is substantially rectangular.

FIG. 5 shows an embodiment of the valve element 9, where the mainportion of the connection portion 13 is substantially rectangular withhook-shaped parts on both ends of the connection portion 13.

In FIG. 6 the connection portion 13 has a similar profile as in FIG. 5,only this one is symmetrical around a horizontal axis. As theanti-reflux device can be in various positions during use, e.g. turnedupside down, the connecting portion 13 may be substantially symmetricalaround a horizontal axis to achieve similar contact surfaces with theretaining means corresponding to the protrusions 10 a, 10 b in FIG. 1regardless of the orientation of the anti-reflux device. It ispreferable that the retaining means of the anti-reflux device, e.g.provided in the first part, are formed in a corresponding manner.

FIG. 7 shows another embodiment of the valve element 9, where theconnection portion 13 is substantially rectangular, but with incisionsin the lower part of the connection portion 13.

The embodiment of the valve element 9 shown in FIG. 8 has a similarprofile as the valve element in FIG. 7, only this one is symmetricalaround a horizontal axis. This shape of the connection portion 13 aswell as the one of FIG. 8 provides the possibility of maximum control ofthe valve element 9 regarding movement in the plane, in which the valveelement extends, e.g. lateral movement.

In FIG. 9 another embodiment of the valve element 9 is shown, where themain portion of the connection portion 13 is rectangular with downwardprojecting parts situated at some distance from the ends of theconnection portion 13. This profile of the connection portion 13provides the possibility of having relatively small contact surfaceswith the retaining means, which enables the valve element 9 to pivotmore freely around the retaining means.

The sheet-shaped material forming the blank 30 may be of any suitablematerial known per se and having suitable dimensions, such as arelatively thin plastic material. As in the previously and subsequentlydescribed embodiments, the provision of integral engagement meansentails that no cut-out or punched-out material in the form of freewaste is produced. There is thus no need for manufacturing stepsincluding the removal of the free waste, as the lattice waste formed iscoherent. This is of particular importance when the dimensions aresmall, as is the case here, as forces resulting i.a. from the staticelectricity generated by handling of the material may exceed otherforces, such as gravity.

FIGS. 10 to 11 show further embodiments of the valve element 9. Theconnection portion 13 of the valve element 9 in FIG. 10 has a similarprofile as the valve element in FIG. 9, only this one is symmetricalaround a horizontal axis. Moreover, examples of contact surfaces A, B,C, D, E between the connection portion 13 and the retaining means (notshown) are indicated to illustrate the numerous contact surfacespossible. The different contact surfaces can be applied in combination.For the sake of simplicity the contact surfaces A, B, C, D, E are onlyindicated in one area of the connection portion 13, but the same optionsapply to the distal end as well as the upper part of the connectionportion 13. FIG. 11 shows an embodiment of the valve element 9, wherethe main portion of the connection portion 13 is rectangular withdownward projecting, substantially triangular parts. In FIG. 11 otherexamples of contact surfaces F, G, H, I, J are shown. It is preferablethat the retaining means of the anti-reflux device, e.g. provided in thefirst part, are formed in a corresponding manner so as to accommodatethe valve element 9 and the contact surfaces.

The embodiment of the valve element 9 shown in FIG. 12 has a similarprofile as the valve element in FIG. 11, only this one is symmetricalaround a horizontal axis.

FIG. 13 shows an embodiment of the valve element 9, where the top andthe sides of the connection portion 13 are substantially perpendicular,whereas the lower parts of the contour of the connection portion 13 aredownward inclined towards the end of the connection portion 13.

In FIG. 14 the connection portion 13 has a similar profile as in FIG.13, only this one is symmetrical around a horizontal axis, i.e. the topof the connection portion 13 has downward inclined parts of the contouras well.

FIG. 15 shows an embodiment of the valve element 9, where the top andthe sides of the connection portion 13 are substantially perpendicular,whereas the lower parts of the contour of the connection portion 13 aredownward inclined towards the middle of the connection portion 13.

The embodiment of the valve element 9 shown in FIG. 16 has a similarprofile as the valve element in FIG. 15, only this one is substantiallysymmetrical around a horizontal axis, i.e. the top of the connectionportion 13 has downward inclined parts of the contour as well.

In FIG. 17 the embodiment of the valve element 9 has a connectionportion 13, which is substantially trapezoidal.

FIG. 18 shows an embodiment of the valve element 9, where the connectionportion 13 is substantially rectangular, and where the flap portion 14is in the shape of a crescent, which ends are connected to theconnection portion 13 via straight lines.

FIG. 19 shows an embodiment of the valve element 9, where the lower andthe upper parts of the contour of the connection portion 13 are downwardinclined towards the ends of the connection portion 13.

As an alternative, the engagement means may be provided within the outercontour of the valve element. It is, however, important that thesheet-shaped material is kept intact during the provision of theengagement means and thus projects a coherent plane. It is furtherpreferable that the retaining means of the anti-reflux device, e.g.provided in the first part, are formed in a corresponding manner.

Examples of such engagement means are shown in FIGS. 20 to 22, in whichonly features regarding the engagement means will be described indetail.

In the embodiment of FIG. 20, the engagement means are formed as a pairof crescent-shaped slits 40 and 41 in the connecting portion 13 of thevalve element 9. The outer contour 15 of the valve element 9 may beformed such that the transition area between the flap portion 14 and theconnecting portion 13 is slightly narrowed.

In FIG. 21 a pair of longitudinally extending slits 40,41 constitute theengagement means.

In FIG. 22, only one set 40 of engagement means is provided in the formof two crossed slits 40 a,40 b. Other configurations and combinations ofsuch slits are of course conceivable, including three sets of engagementmeans cooperating with a corresponding number of retaining means of thedevice.

FIG. 23 shows an embodiment of the invention, where the retaining means10 a, 10 b are two protrusions in the shape of pins which protrude fromthe back wall of the recess 11 (not shown). Upper retaining means 32 isalso provided in the shape of a substantially flat surface, againstwhich the valve element 9 can rest if for example the anti-reflux deviceis placed upside down.

In FIG. 24 another embodiment of the invention is shown, in which theretaining means 10 a, 10 b are in the shape of pins, and the upperretaining means 32 is provided with downward projecting parts

FIG. 25 shows yet another embodiment of the invention, in which theretaining means 10 a, 10 b as well as the upper retaining means 32 arein the shape of pins.

The appended drawings are schematic, i.e. they are schematic examples ofembodiments of the invention. For example the shape of the flap portion14 and/or the different angles of the connection portion 13 can bealtered, or the corners can be rounded which will improve thefunctionality and hygiene of the device as corners are eliminatedcausing the urine to flow more freely.

The invention should not be regarded as being limited to the embodimentsdescribed in the above and shown in the drawings. Various modificationsand combinations are conceivable without departing from the scope of theappended claims.

1. A body fluids drainage system comprising: a urinary catheter; adrainage collection bag; and a connection member connected between theurinary catheter and the drainage collection bag, the connection memberhousing a valve element formed from a sheet of material and projecting acoherent plane, the valve element defining a longitudinal directionextending between a connecting portion and a flap portion and a recessformed on a periphery of the valve element between the connectingportion and the flap portion.
 2. The body fluids drainage system ofclaim 1, wherein the connecting portion includes a hook-shapedengagement section formed integrally with the valve element andconfigured to engage with the connection member.
 3. The body fluidsdrainage system of claim 1, wherein the recess is formed to extend in adirection substantially transverse to the longitudinal direction.
 4. Thebody fluids drainage system of claim 1, wherein the valve elementdefines a first recess formed on a first side of the periphery of thevalve element between the connecting portion and the flap portion and asecond recess formed on a second side of the periphery of the valveelement between the connecting portion and the flap portion.
 5. A bodyfluids drainage system comprising: a urinary catheter; a drainagecollection bag; and a connection member connected between the urinarycatheter and the drainage collection bag, the connection member housinga valve element formed from a sheet of material and projecting acoherent plane, the valve element defining a longitudinal directionextending between a connecting portion and a flap portion; wherein theconnecting portion includes a hook-shaped engagement section formedintegrally with the valve element for engagement with the connectionmember.
 6. The body fluids drainage system of claim 5, wherein thehook-shaped engagement section is formed from an incision in a peripheryof the valve element that extends substantially transverse with respectto the longitudinal direction.
 7. The body fluids drainage system ofclaim 6, wherein the incision is formed at a transition between the flapportion and the connecting portion.
 8. A body fluids drainage systemcomprising: means for draining urine from a bladder; means forcollecting the urine drained from the bladder; and means for housing avalve within the system, the valve formed from a sheet of material toproject a coherent plane and having a connecting portion and a flapportion and a recess formed on a periphery of the valve between theconnecting portion and the flap portion.
 9. The body fluids drainagesystem of claim 8, wherein the valve comprises an anti-reflux valveconfigured to prevent backflow of the urine toward the bladder.
 10. Thebody fluids drainage system of claim 8, wherein the valve is flexibleand configured for movement of the flap portion relative to theconnecting portion.